CIMZIA® (certolizumab pegol) has a demonstrated safety profile

Incidence of serious adverse events of interest

Incidence of serious adverse events in CIMZIA clinical trials (per 100 patient-years)1,5

  CIMZIA Placebo
TUBERCULOSIS
(IN COMPLETED AND
ONGOING CLINICAL
STUDIES*)
0.61
(n=5118)
0
(n=1563)
MALIGNANCIES
(IN CLINICAL TRIALS*)
0.5 (0.4-0.7)
(n=4650)
0.6 (0.1-1.7)
(n=1319)
LYMPHOMA
(IN RA CLINICAL TRIALS)
0.09
(0.02-0.27)
(n=2367)
0
(n=647)
  • Incidence of serious infections during controlled clinical studies was 3% per patient-year for patients treated with CIMZIA and 1% for placebo1
  • Cases of new or worsening congestive heart failure have been reported with TNF blockers, including CIMZIA1
  • In controlled trials in CD and other investigational uses, there was one case of lymphoma among 2657 CIMZIA patients1
See Warnings and Precautions, including Boxed Warning, regarding tuberculosis, malignancies, and lymphoma.
  • Including other investigational uses.
  • Includes patients from placebo arms from phase 2 and 3 controlled clinical trials in RA and Crohn's disease.
  • Numbers in parentheses represent a 95% confidence interval.

Common adverse events

Most common adverse reactions (≥5% of CIMZIA-treated patients and with a higher incidence compared to placebo) in controlled CD clinical studies1

  CIMZIA
(n=620)
Placebo
(n=614)
Upper respiratory tract infection 20% 13%
Urinary tract infection 7% 6%
Arthralgia 6% 4%
  • Less than 2% of CIMZIA patients reported injection site burning or stinging in clinical trials2
  • In premarketing controlled trials of all patient populations combined, the most common adverse reactions (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%)